Title 21, Part 10 — Administrative Practices and Procedures
31 sections
Section 10.1
Scope.
Section 10.3
Definitions.
Section 10.10
Summaries of administrative practices and procedures.
Section 10.19
Waiver, suspension, or modification of procedural requirements.
Section 10.20
Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.
Section 10.25
Initiation of administrative proceedings.
Section 10.30
Citizen petition.
Section 10.31
Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications.
Section 10.33
Administrative reconsideration of action.
Section 10.35
Administrative stay of action.
Section 10.40
Promulgation of regulations for the efficient enforcement of the law.
Section 10.45
Court review of final administrative action; exhaustion of administrative remedies.
Section 10.50
Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.
Section 10.55
Separation of functions; ex parte communications.
Section 10.60
Referral by court.
Section 10.65
Meetings and correspondence.
Section 10.70
Documentation of significant decisions in administrative file.
Section 10.75
Internal agency review of decisions.
Section 10.80
Dissemination of draft Federal Register notices and regulations.
Section 10.85
Advisory opinions.
Section 10.90
Food and Drug Administration regulations, recommendations, and agreements.
Section 10.95
Participation in outside standard-setting activities.
Section 10.100
Public calendar.
Section 10.105
Representation by an organization.
Section 10.110
Settlement proposals.
Section 10.115
Good guidance practices.
Section 10.200
Scope.
Section 10.203
Definitions.
Section 10.204
General.
Section 10.205
Electronic media coverage of public administrative proceedings.
Section 10.206
Procedures for electronic media coverage of agency public administrative proceedings.